§ 862.1542. Oxalate test system.
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/us/cfr/t21/s§ 862.1542·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An oxalate test system is a device intended to measure the concentration of oxalate in urine. Measurements of oxalate are used to aid in the diagnosis or treatment of urinary stones or certain other metabolic disorders.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]